Author: Michelle Dryden

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Culture Healthcare Science

Hinge Health appoints Mario Queiroz as chief product officer

Industry veteran brings a wealth of experience and expertise in building industry-leading products

SAN FRANCISCO — (BUSINESS WIRE) — Hinge Health, the world’s #1 Digital Musculoskeletal Clinic™, today announced the appointment of Mario Queiroz as chief product officer. In this role, Queiroz will be responsible for driving the company’s product strategy and innovations to make musculoskeletal (MSK) care more accessible, affordable, and equitable for employers and members. Queiroz is a widely respected product leader and previously led product functions at Palo Alto Networks, Google, and HP.


“Mario is an exceptional product thinker and builder with a track record of developing some of the most popular consumer products in the world,” said Gabriel Mecklenburg, co-founder and chairman, Hinge Health. “I’m really excited to welcome him to our leadership team as we continue to build magical experiences for our members.”

 

Queiroz’s appointment comes at a time when the company is growing its offering across the full continuum of MSK care. In April, the company announced a Women’s Pelvic Health program to address the grossly underserved pelvic health needs of millions of women across America. This followed many product launches over the last year, including the release of HingeConnect for more seamless care between digital and in-person providers and Enso, wearable technology for electrical nerve stimulation. Hinge Health also acquired wrnch, one of the world’s most advanced computer vision companies, for pose estimation. This technology will allow members to use the camera on their phones to guide them through a wider pool of exercises and treat areas that are difficult to assess with physical sensors – all through a modern, delightful member experience.

 

“Millions of Americans experience chronic back and joint pain. As someone deeply passionate about leading an active lifestyle, I understand how important it is for people to have easy access to comprehensive, top-quality pain care so they can keep living their lives to the fullest,” said Mario Queiroz. “I am deeply inspired by Hinge Health’s product vision for accessible and personalized care and the opportunity to shape experiences that can transform people’s lives.”

 

Queiroz brings nearly three decades of product leadership experience to Hinge Health. He most recently served as executive vice president of special projects at Palo Alto Networks, where he led the creation of a new product line to bring enterprise-grade cybersecurity to people’s homes and to small businesses. Before Palo Alto Networks, Queiroz was at Google for 14 years. He led several of Google’s biggest consumer hardware projects, from Chromecast to Google Home, to having last served as general manager and vice president of product management for Pixel smartphones. He also held various leadership roles at HP. Queiroz holds a Bachelor’s and Master of Science in electrical engineering from Stanford University.

 

About Hinge Health

Hinge Health is building the world’s most patient-centered Digital Musculoskeletal (MSK) Clinic™. It is now the leading Digital MSK Clinic, used by four in five employers and 90% of health plans with a digital MSK solution. Hinge Health reduces MSK pain, surgeries, and opioid use by pairing advanced wearable sensors and computer vision technology with a comprehensive clinical care team of physical therapists, physicians, and health coaches. Hinge Health’s HingeConnect integrates with 1 million+ in-person providers and enables real-time interventions for elective MSK surgeries, driving proven medical claims reduction. Available to millions of members, Hinge Health is widely trusted by leading organizations, including Land O’Lakes, L.L. Bean, Salesforce, Self-Insured Schools of California, Southern Company, State of New Jersey, US Foods, and Verizon. Learn more at http://www.hingehealth.com.

Contacts

Erica Osian

media@hingehealth.com

Categories
Business Science Technology

Velodyne Lidar wins GeoBuiz Summit Award for innovation in Mapping Technology

Velodyne’s Intelligent Infrastructure Solution Creates 3D Maps of Roads and Intersections to Advance Safety in Communities Globally

 

SAN JOSE, Calif. — (BUSINESS WIRE) — #Lidar—Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today announced its Intelligent Infrastructure Solution won the GeoBuiz Summit Award. Velodyne’s smart city solution was recognized for excellence in innovation in the Mapping Technology category.


Intelligent Infrastructure Solution, combining Velodyne’s award-winning lidar sensors and Bluecity’s AI software, creates a real-time 3D map of roads and intersections. It provides precise traffic monitoring and analytics that are not possible with other types of sensors like cameras, radar or inductive loops.

 

The full stack solution is deployed across three continents, including systems rolled out in Texas, Florida, Nevada, California, New Jersey, Missouri and Canada.

 

Intelligent Infrastructure Solution enables cities and states to take a proactive approach on safety by offering real-time multimodal analytics of not only vehicles, but also vulnerable road users. It is helping communities understand root causes of near-miss collisions, red light running and different types of roadway user behavior.

 

By improving traffic flow and reducing congestion, Intelligent Infrastructure Solution can improve energy efficiency and reduces greenhouse gas emissions for a more sustainable future. Earlier this year, the solution won the 2022 SXSW Innovation Awards from the South by Southwest Conference and Festivals.

 

“Velodyne’s Intelligent Infrastructure Solution was the standout system in our Mapping Technology category,” said Anusuya Datta, Editor – Americas, Geospatial World. “The solution is transforming infrastructure, enabling governments to build a data-driven plan to create a safer, more sustainable traffic network.”

 

“Our solution supports cities throughout the world as they work to implement street improvements, policy changes and educational efforts that will protect vulnerable road users,” said Sally Frykman, Chief Marketing Officer, Velodyne Lidar. “Intelligent Infrastructure Solution advances Velodyne’s mission of creating smart technologies for a world in motion and their vision of science in service of safety.”

 

GeoBuiz Summit is a one-of-a-kind geospatial business leaders conference that is held by Geospatial World, a premier media outlet that advances geospatial knowledge in the world economy and society. Geospatial World recently featured Velodyne Lidar CEO Dr. Ted Tewksbury in an article about how Velodyne’s lidar sensors and software are playing an important role in applications including in geospatial and mapping, as well as last mile delivery, industrial and robotics, manufacturing and infrastructure.

 

For more information on the Intelligent Infrastructure Solution, contact Velodyne Sales: 669.275.2526, sales@velodyne.com, and watch the IIS overview video.

 

About Velodyne Lidar

Velodyne Lidar (Nasdaq: VLDR, VLDRW) ushered in a new era of autonomous technology with the invention of real-time surround view lidar sensors. Velodyne, the global leader in lidar, is known for its broad portfolio of breakthrough lidar technologies. Velodyne’s revolutionary sensor and software solutions provide flexibility, quality and performance to meet the needs of a wide range of industries, including robotics, industrial, intelligent infrastructure, autonomous vehicles and advanced driver assistance systems (ADAS). Through continuous innovation, Velodyne strives to transform lives and communities by advancing safer mobility for all.

 

Forward Looking Statements

This press release contains “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995 including, without limitation, all statements other than historical fact and include, without limitation, statements regarding Velodyne’s target markets, new products, development efforts, and competition. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “can,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Velodyne’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include uncertainties regarding government regulation and adoption of lidar, the uncertain impact of the COVID-19 pandemic on Velodyne’s and its customers’ businesses; Velodyne’s ability to manage growth; Velodyne’s ability to execute its business plan; uncertainties related to the ability of Velodyne’s customers to commercialize their products and the ultimate market acceptance of these products; the rate and degree of market acceptance of Velodyne’s products; the success of other competing lidar and sensor-related products and services that exist or may become available; uncertainties related to Velodyne’s current litigation and potential litigation involving Velodyne or the validity or enforceability of Velodyne’s intellectual property; and general economic and market conditions impacting demand for Velodyne’s products and services. For more information about risks and uncertainties associated with Velodyne’s business, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” sections of Velodyne’s SEC filings, including, but not limited to, its annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements in this press release are based on information available to Velodyne as of the date hereof, Velodyne undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Velodyne Investor Relations

InvestorRelations@velodyne.com

Media

Codeword

Liv Allen

velodyne@codewordagency.com

Categories
Business Healthcare International & World Science

Patritumab Deruxtecan continues to show promising clinical activity in patients across subtypes of metastatic breast or lung cancer

  • Data from a phase 1/2 trial in patients with several subtypes of HER3 expressing metastatic breast cancer featured as oral presentation at ASCO
  • First presentation of phase 1 data from a cohort of patients with advanced NSCLC without EGFR mutations also highlighted in poster discussion session

 

TOKYO & MUNICH & BASKING RIDGE, N.J.–(BUSINESS WIRE)–New data from Daiichi Sankyo’s (TSE: 4568) patritumab deruxtecan (HER3-DXd) showed clinically meaningful and durable responses in two early-stage trials in previously treated patients with HER3 expressing metastatic breast cancer or advanced non-small cell lung cancer (NSCLC) without EGFR-activating mutations. These data will be presented during an oral presentation (Abstract #1002) and a poster discussion session (Abstract #9017) at the American Society of Clinical Oncology (#ASCO22) Annual Meeting.

Patritumab deruxtecan is a potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.

 

Advanced breast and lung cancer are two of the leading causes of cancer-related death in the U.S. with five-year survival rates of 30% and 7%, respectively.1,2 New therapeutic approaches are needed to improve outcomes for these cancers and HER3 is a promising target for therapeutic development. HER3 is broadly expressed in these tumors and is associated with an increased incidence of metastases, reduced survival and is one of the mechanisms of resistance to standard of care treatment.3,4

 

“Results of these two trials of patritumab deruxtecan in patients with certain subtypes of advanced breast or lung cancer further support the potential of Daiichi Sankyo’s DXd antibody drug conjugate technology across different types of cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “These data also reinforce the potential emerging role of targeting HER3 with an antibody drug conjugate to overcome resistance to standard of care treatment in patients with HER3 expressing metastatic breast cancer as well as in patients with advanced non-small cell lung cancer without EGFR activating mutations, which we plan to continue to explore in additional trials.”

 

HER3 Expressing Metastatic Breast Cancer Results

Pooled analysis from a three-part, first-in-human phase 1/2 trial evaluating patritumab deruxtecan (n=182) showed clinically meaningful and durable responses after a median follow-up of 31.9 months (range, 15-56) in patients with three different subtypes of HER3 expressing metastatic breast cancer, including HR positive/HER2 negative, triple negative and HER2 positive disease. Responses were seen across a broad range of HER3 expression.

 

A confirmed objective response rate (ORR) of 30.1% (95% CI: 21.8-39.4) was observed with patritumab deruxtecan in the cohort of 113 patients with HER3 high or HER3 low, HR positive/HER2 negative metastatic breast cancer, as assessed by blinded independent central review (BICR). Partial responses (PRs) were observed in 30.1% of patients and 50.4% of patients had a best overall response (BOR) of stable disease (SD). Median duration of response (DOR) was at 7.2 months (95% CI: 5.3-NE). Median progression-free survival (PFS) was 7.4 months (95% CI: 4.7-8.4) and median overall survival (OS) was 14.6 months (95% CI: 11.3-19.5).

 

In the cohort of 53 patients with HER3 high metastatic triple negative breast cancer (TNBC), an ORR of 22.6% (95% CI: 12.3-36.2) was observed with patritumab deruxtecan, as assessed by BICR. PRs were observed in 22.6% of patients and 56.6% of patients had a BOR of SD. Median DOR was 5.9 months (95% CI: 3.0-8.4). Median PFS was 5.5 months (95% CI: 3.9-6.8) and the median OS was 14.6 months (95% CI: 11.2-17.2).

 

An ORR of 42.9% (95% CI: 17.7-71.1) was observed with patritumab deruxtecan in the cohort of 14 patients with HER3 high, HER2 positive metastatic breast cancer, as assessed by BICR. PRs were observed in 42.9% of patients and 50.0% of patients had a BOR of SD. Median DOR was 8.3 months (95% CI: 2.8-26.4). Median PFS was 11.0 months (95% CI: 4.4-16.4) and median OS was at 19.5 months (95% CI: 12.2-NE).

 

“Significant unmet need still remains for the treatment of patients with metastatic breast cancer and new treatment strategies need to be continuously explored,” said Ian E. Krop, MD, PhD, Chief Clinical Research Officer, Associate Cancer Center Director for Clinical Research, Yale Cancer Center. “Results from this trial show that patritumab deruxtecan produces clinically meaningful and durable antitumor activity in patients and further study is warranted to further evaluate the efficacy and safety of this HER3 directed antibody drug conjugate across patients with HR positive/HER2 negative, HER2 positive and triple negative breast cancer.”

 

Pooled safety was analyzed for all patients (n=182) enrolled in the trial. Treatment-emergent adverse events (TEAEs) associated with treatment discontinuation was 9.9%. Treatment-related Grade ≥ 3 TEAEs occurred in 120 patients (65.9%) and included neutrophil count decrease, platelet count decrease, white blood cell count decrease, anemia, alanine aminotransferase increase, aspartate aminotransferase increase, decreased appetite, nausea, fatigue, diarrhea, malaise, stomatitis and vomiting. Overall, 12 patients (6.6%) had confirmed treatment-related interstitial lung disease (ILD) or pneumonitis as determined by an independent adjudication committee. Most ILD events were low-grade with three (1.6%) grade 1 and five (2.7%) grade 2 events; three grade 3 (1.6%) and one grade 5 (death) event occurred (0.5%).

 

Patients were heavily pre-treated, and those with HR positive/HER2 negative metastatic breast cancer had received a median of six (range, 2-13) prior lines of therapy in the advanced setting; patients with metastatic TNBC had received a median of two (range, 1-13) prior therapies; and patients with HER2 positive breast cancer had received a median of 5.5 (range, 2-11) prior therapies. Median treatment duration was 5.9 months (range, 0.7-30.6). As of the data cut-off on August 16, 2021, four patients remained on study treatment with patritumab deruxtecan.

 

Summary of Results of HER3 Expressing Breast Cancer Phase 1/2 Trial

Efficacy Measures

HR positive/

HER2 negative

HER3 high and

HER3 low

n=113

TNBC

HER3 high

n=53

HER2 positive

HER3 high

n=14

Confirmed ORR, % (95% CI)i

30.1% (21.8-39.4)

22.6% (12.3-36.2)

42.9% (17.7-71.1)

Confirmed BOR

PR, % (n)

30.1% (34)

22.6% (12)

42.9% (6)

SD, % (n)

50.4% (57)

56.6% (30)

50.0% (7)

PD, % (n)

11.5% (13)

17.0% (9)

7.1% (1)

NE, % (n)

8.0% (9)

3.8% (2)

0% (0)

DOR, median (95% CI), months

7.2 months

(5.3-Not Estimable)

5.9 months (3.0-8.4)

8.3 months (2.8-26.4)

PFS, median (95% CI), months

7.4 months (4.7-8.4)

5.5 months (3.9-6.8)

11.0 months (4.4-16.4)

6-month PFS rate, % (95% CI)

53.5% (43.4-62.6)

38.2% (24.2-52.0)

51.6% (22.1-74.8)

OS, median (95% CI), months

14.6 months (11.3-19.5)

14.6 months (11.2-17.2)

19.5 months

(12.2-Not Estimable)

 

BOR, best overall response; DOR, duration of response; HER, human epidermal growth factor receptor; HR, hormone receptor; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease; NE, not evaluable; TNBC, triple negative breast cancer

i 95% exact binomial confidence interval using Clopper-Pearson method

 

NSCLC Without Common EGFR-Activating Mutations Results

First preliminary results from one cohort of an ongoing phase 1 trial reported durable responses with patritumab deruxtecan after a median follow-up of 19.7 months (range, 13.8-29.2) in patients with locally advanced or metastatic NSCLC without most frequent EGFR activating mutations (EX19del, L858R, L861Q or G719X) or without identified driver genomic alterations.

 

An ORR of 28.6% (95% CI: 11.3-52.2), as assessed by BICR, was observed with patritumab deruxtecan in 21 patients with advanced NSCLC with identified driver genomic alterations other than EGFR activating mutations. Six patients had PRs and 10 patients had a best overall response of stable disease. Median DOR was 9.4 months (95% CI: 4.2-NE) and a disease control rate (DCR) of 76.2% (95% CI: 52.8-91.8) was observed. Median PFS was 10.8 months (95% CI: 2.8-16.0). Responses with patritumab deruxtecan were seen in patients with a broad range of driver genomic alterations, including KRAS/NRAS mutations and ALK fusions.

 

In patients with NSCLC without identified driver genomic alterations, an ORR of 26.9% (95% CI: 11.6-47.8) was observed with patritumab deruxtecan in 26 patients, as assessed by BICR. One patient had a complete response (CR), six had PRs and 12 patients had stable disease as a best overall response. Median DOR was 9.6 months (95% CI: 1.6-NE) and a DCR of 73.1% (95% CI: 52.2-88.4) was observed.

 

“Similar to previously reported results in patients with EGFR mutated non-small cell lung cancer, patritumab deruxtecan shows promising durable responses in patients with heavily pretreated advanced non-small cell lung cancer with or without driver genomic alterations,” said Conor E. Steuer, MD, Assistant Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine. “Further research is warranted to further confirm whether targeting HER3 is an effective treatment strategy to overcome treatment resistance in these patients.”

 

Safety of patritumab deruxtecan seen in this cohort was consistent with that previously observed in patients with EGFR-mutated NSCLC. Treatment-related Grade ≥ 3 TEAEs occurred in 24 patients (51.1%) and included neutropenia, fatigue, thrombocytopenia, hypokalemia, anemia, leukopenia and pneumonia. Five patients (10.6%) had confirmed treatment-related ILD as determined by an independent adjudication committee. Most of these ILD events were low-grade with one grade 1 (2.1%) and four grade 2 (8.5%) events. As of data cut-off of January 28, 2022, five patients (10.6%) remained on treatment with patritumab deruxtecan.

 

About the Phase 1/2 Breast Cancer Trial

The global, open-label, three-part phase 1/2 trial is evaluating the safety and efficacy of patritumab deruxtecan in patients with HER3 expressing advanced/unresectable metastatic breast cancer who are refractory or intolerant to standard treatment, or for whom no standard treatment is available.

 

The dose escalation part of the trial is assessing the safety and tolerability of increasing doses of patritumab deruxtecan to determine the maximum tolerated dose. The dose finding part of the trial assessed the safety and efficacy of patritumab deruxtecan at selected dosing levels to determine the recommended dose for expansion. Patients in the dose escalation and dose finding parts of the trial must have received six or fewer prior chemotherapy regimens, at least two of which were administered for treatment of advanced/unresectable metastatic disease, and at least one prior chemotherapeutic regimen must have included a taxane, administered in the neoadjuvant, adjuvant or advanced setting.

 

The phase 2 part of the trial is evaluating the safety and efficacy of patritumab deruxtecan at the recommended dose for expansion in four different cohorts of patients with HER3 expressing and HER2 negative locally advanced or metastatic breast cancer, including HR positive and triple negative breast cancer. For more information, visit ClinicalTrials.gov.

 

About the Phase 1 Non-Small Cell Lung Cancer Trial

The global, multicenter, open label, two-part phase 1 trial is evaluating patritumab deruxtecan in previously treated patients with metastatic or unresectable NSCLC.

 

The dose escalation part of the trial is evaluating patients with EGFR-mutated disease either with progression on osimertinib or T790M-negative after progression on erlotinib, gefitinib or afatinib. The primary objective of this part of the trial was to assess the safety and tolerability of patritumab deruxtecan and determine the recommended dose for expansion (RDE).

 

The dose expansion part of the trial is evaluating patritumab deruxtecan at the RDE (5.6 mg/kg every three weeks) in three cohorts. Cohort 1 includes patients with locally advanced or metastatic EGFR-mutated NSCLC who experienced disease progression after taking one or more EGFR TKIs and one or more platinum-based chemotherapy regimens. Cohort 2 includes patients with squamous or non-squamous NSCLC without EGFR-activating mutations following platinum-based chemotherapy and following an anti-PD-1 or anti-PD-L1 antibody regimen. Cohort 3 includes patients with NSCLC with EGFR-activating mutations including any histology other than combined small cell and non-small cell lung cancer; patients in Cohort 3 are randomized 1:1 to receive the 5.6 mg/kg RDE regimen (Cohort 3a) or an escalating up-titration regimen of patritumab deruxtecan (Cohort 3b).

 

The primary objective of the dose expansion part of the trial is to assess efficacy of patritumab deruxtecan as measured by confirmed objective response rate (ORR) assessed by blinded independent central review. Secondary trial endpoints include investigator-assessed ORR, safety and pharmacokinetics. The trial enrolled patients at multiple sites in Asia, Europe and North America. For more information, visit ClinicalTrials.gov.

 

About Breast Cancer and Non-Small Cell Lung Cancer

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.5 More than two million cases of breast cancer were diagnosed in 2020 with nearly 685,000 deaths globally.5 The five-year survival rate of advanced breast cancer is 30% in the U.S.1

 

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.6 More than 2.2 million cases of lung cancer were diagnosed in 2020, resulting in nearly 1.8 million deaths globally.6 NSCLC accounts for about 84% of all lung cancers.7 About half of patients with NSCLC are diagnosed at an advanced stage and they often have a poor prognosis with worsening outcomes after each line of subsequent therapy.8,9,10 The five-year survival rate of advanced lung cancer is 7% in the U.S.2

 

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.3 It is estimated that about 83% of all NSCLC tumors express the HER3 protein. Overexpression is associated with metastatic progression and decreased relapse-free survival.11 Currently, no HER3 directed medicines are approved for the treatment of any cancer.

 

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is comprised of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other anticancer therapies. The development program includes HERTHENA-Lung01, a pivotal phase 2 study in patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with a TKI and platinum-based chemotherapy; a phase 1/2 study in HER3 expressing metastatic breast cancer; a phase 1 study in combination with osimertinib in locally advanced/metastatic EGFR-mutated NSCLC; and, a phase 1 study in previously treated patients with metastatic or unresectable NSCLC.

 

In December 2021, patritumab deruxtecan was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic or locally advanced EGFR-mutated NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

 

Patritumab deruxtecan is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

 

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit: www.daiichisankyo.com.

References:

_______________________

1 National Cancer Institute. Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed May 2022.

2 National Cancer Institute. Cancer Stat Facts: Lung and Bronchus. Accessed May 2022.

3 Mishra R, et al. Oncol Rev. 2018;12(1):355.

4 Ocana A, et al. J Natl Cancer Inst. 2013 Feb 20;105(4):266-73.

5 Sung H, et al. CA Cancer J Clin. 2021; 10.3322/caac.21660.

6 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed May 2022.

7 American Cancer Society. What is Lung Cancer? 2019. Accessed May 2022.

8 Siegel R, et al. CA Cancer J Clin. 2021;71:7-33.

9 Walters S, et al. Thorax. 2013;68:551-564.

10 Hardstock F, et al. BMC Cancer. 2020;20(1):260.

11 Scharpenseel H, et al. Sci Rep. 2019;9[1]:7406.

Contacts

Global/US:
Sarah McGovern

Daiichi Sankyo, Inc.

smcgovern@dsi.com
+1 908 992 6614 (office)

+1 908 821 7376 (mobile)

EU:
Simone Jendsch-Dowe

Daiichi Sankyo Europe GmbH

simone.dowe@daiichi-sankyo.eu
+49 (176) 11780822 (mobile)

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Categories
Business Healthcare Science

Legend Biotech announces U.S. FDA clearance of IND application for solid tumor CAR-T, LB1908 for relapsed or refractory gastric, esophageal and pancreatic cancers

SOMERSET, N.J. — (BUSINESS WIRE) — $LEGN–Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate LB1908 in a Phase 1 clinical trial in the United States. LB1908 is an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy selectively targeting Claudin 18.2 through a high-affinity VHH antibody for the treatment of adults with relapsed or refractory gastric, esophageal (including gastro-esophageal junction) or pancreatic cancers. Claudin18.2 is a tight junction protein commonly expressed in patients with these cancer subtypes.1

The Phase 1, first-in-human, open-label, multicenter clinical study seeks to characterize the safety and tolerability of LB1908, as well as determine the recommended dose for Phase 2 and evaluate preliminary efficacy. Study will have dose escalation and dose expansion phases. Patients enrolled in the study must sufficiently express Claudin 18.2.

 

A Phase 1 investigator-initiated trial evaluating LB1908 for advanced gastric cancers is also ongoing in China (NCT04467853).

 

“Treatment options for patients with esophageal, stomach and pancreatic cancers have improved in the last ten years, but patients in the advanced stages still face poor prognoses worldwide. Thousands of people have no symptoms until their cancers have moved into late phases and at that point, surgery is no longer an option,” said Lida Pacaud, M.D., Vice-President of Clinical Development. “Based on prevailing research, we are optimistic that a CAR-T therapy targeting Claudin 18.2 can be integrated in future treatment strategies for those with relapsed or refractory gastrointestinal cancers. We look forward to the start of the trial.”

 

About Gastric, Esophageal and Pancreatic Cancers

Stomach, esophageal and pancreatic cancers affect the tissue or glands lining these organs. They are often diagnosed when the diseases have progressed to advanced stages. In the U.S., there are an estimated 123,920 people living with stomach cancer and 49,084 living with esophageal cancers.2,3 An estimated 89,248 people in the U.S. live with pancreatic cancer. While all three cancers are treatable, the five-year survival rate is just 32% for gastric cancer; 20% for esophageal cancer; and 11.5% for pancreatic cancer, with definitive treatment at all stages of progression.4,5,6

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

 

Learn more at www.legendbiotech.com and follow us on Twitter and LinkedIn.

 

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to CARVYKTI™, including Legend Biotech’s expectations for CARVYKTI™, such as Legend Biotech’s manufacturing and commercialization expectations for CARVYKTI™ and the potential effect of treatment with CARVYKTI™; statements about submissions for cilta-cel to, and the progress of such submissions with, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Chinese Center for Drug Evaluation of National Medical Products Administration (CDE) and other regulatory authorities; the anticipated timing of, and ability to progress, clinical trials, including patient enrollment; the submission of Investigational New Drug (IND) applications to, and maintenance of such applications with, regulatory authorities; the ability to generate, analyze and present data from clinical trials; and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of the Legend Biotech’s Annual Report filed with the Securities and Exchange Commission on March 31, 2022. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected.​ Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

References

____________________

1 Arnold, A. Prognostic impact of Claudin 18.2 in gastric and esophageal adenocarcinomas. Clinical and Translational Oncology. 2020;22:2357-2363.

2 Surveillance, Epidemiology, and End Results (SEER) Program. https://seer.cancer.gov/statfacts/html/stomach.html. Accessed May 2022.

3 Surveillance, Epidemiology, and End Results (SEER) Program. https://seer.cancer.gov/statfacts/html/esoph.html. Accessed May 2022.

4 American Cancer Society. https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 2022.

5 American Cancer Society. https://www.cancer.org/cancer/esophagus-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 2022.

6 Surveillance, Epidemiology, and End Results (SEER) Program. https://seer.cancer.gov/statfacts/html/pancreas.html. Accessed May 2022.

Contacts

Investor:
Joanne Choi, Senior Manager, Investor Relations, Legend Biotech

joanne.choi@legendbiotech.com

Crystal Chen, Manager, Investor Relations, Legend Biotech

crystal.chen@legendbiotech.com

Press:
Tina Carter, Corporate Communications Lead, Legend Biotech

tina.carter@legendbiotech.com
(908) 331-5025

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Universal Display Corporation and Adesis, Inc. announce sponsorship and participation in MARM 2022

EWING, N.J. — (BUSINESS WIRE) — $OLED #AdesisInc—Universal Display Corporation (Nasdaq: OLED), enabling energy-efficient displays and lighting with its UniversalPHOLED® technology and materials, and Adesis, Inc., a leading contract research organization and a wholly-owned subsidiary of Universal Display Corporation (UDC), today announced its sponsorship and participation in the 2022 Middle Atlantic Regional Meeting (MARM) of the American Chemical Society (ACS), which will be held June 1-4 at The College of New Jersey. This year’s MARM theme is “Our Chemical Revolution,” and will emphasize diversity, equity, and inclusion, highlight advances in science and recognize the achievements of outstanding chemists.

“With Universal Display and Adesis being leaders in chemistry innovation and commercialization, we are pleased to sponsor and participate in the 50th Middle Atlantic Regional Meeting,” said Steven V. Abramson, President and Chief Executive Officer of Universal Display Corporation. “MARM brings together leading scientists to discuss the latest advances in chemistry, molecular modeling, nanotechnology, polymer science, and related fields. As a pioneering technology innovator, UDC supports an expanding range of educational initiatives designed to inspire and encourage future generations interested in Science, Technology, Engineering and Math (STEM) fields. We are delighted to support regional students with conference scholarships to attend MARM and to sponsor the research poster session.”

 

Universal Display Corporation and Adesis, Inc. are sponsors of MARM 2022. Universal Display is sponsoring conference registration for ten students, which will be distributed equitably by conference organizers. Adesis is a research poster session sponsor. In addition, UDC and Adesis will be on-site for the MARM expo and career fair. Participants for MARM 2022 include:

 

  • Dr. George Fitzgerald, Director of Computational Chemistry of UDC, is MARM 2022’s Division Chair for Industrial and Engineering Chemistry. Dr. Fitzgerald recruited symposia organizers in the areas of Organic Synthesis, Applications of Crystal Engineering, Sustainable Chemistry, Molecular Modeling, and Advances in Battery Technology.
  • Linda MacDonald, Chief Operating Officer of Adesis, will give a presentation on breaking brain barriers to effect successful organizational change titled, “Leading Change.”
  • Dr. Zhenzhen Dong, Associate Director of Chemistry of Adesis, organized a symposium on organic chemistry, “Pairings in Organic Chemistry,” where speakers will present different aspects of current research challenges.
  • Dr. Rasha Hamze, Senior Research Scientist of UDC, will give a presentation on her research into luminescent materials titled, “Luminescence of Heavy and Light Metals.”
  • Dr. Elena Sheina, Senior Research Scientist of UDC, organized a symposium on “Advances in Battery Technology for the 21st Century,” featuring the latest work from both academic and commercial research scientists.
  • Dr. Joseph Macor, Senior Research Scientist of UDC, as general MARM volunteer in his role as Board Member of the Trenton Local Section of ACS.

 

About Universal Display Corporation

Universal Display Corporation (Nasdaq: OLED) is a leader in the research, development and commercialization of organic light emitting diode (OLED) technologies and materials for use in display and solid-state lighting applications. Founded in 1994 and with subsidiaries and offices around the world, the Company currently owns, exclusively licenses or has the sole right to sublicense more than 5,500 patents issued and pending worldwide. Universal Display licenses its proprietary technologies, including its breakthrough high-efficiency UniversalPHOLED® phosphorescent OLED technology that can enable the development of energy-efficient and eco-friendly displays and solid-state lighting. The Company also develops and offers high-quality, state-of-the-art UniversalPHOLED materials that are recognized as key ingredients in the fabrication of OLEDs with peak performance. In addition, Universal Display delivers innovative and customized solutions to its clients and partners through technology transfer, collaborative technology development and on-site training. To learn more about Universal Display Corporation, please visit https://oled.com/.

 

About Adesis, Inc.

As a wholly-owned subsidiary of Universal Display Corporation, Adesis is a contract research organization (CRO) supporting the pharma, biotech, catalysis and a number of other industries. The CRO specializes in organic and organometallic synthesis, in milligrams to multi-kilogram quantities. Adesis has a business model of providing clients with organic chemistry services in three areas: early stage research, scale up and development, and specialty manufacturing. With over 20 years of success and approximately 100 chemists with extensive industry and professional experience, Adesis supports companies in various industries with small molecule organic chemistry expertise. Adesis provides a range of services that can supplement research and development efforts. It can also act as a specialty manufacturer to reinforce supply chains and protect sensitive intellectual property. To learn more about Adesis, please visit http://adesisinc.com/.

 

Universal Display Corporation and the Universal Display Corporation logo are trademarks or registered trademarks of Universal Display Corporation. All other company, brand or product names may be trademarks or registered trademarks.

 

All statements in this document that are not historical, such as those relating to the projected adoption, development and advancement of the Company’s technologies, and the Company’s expected results and future declaration of dividends, as well as the growth of the OLED market and the Company’s opportunities in that market, are forward-looking financial statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are cautioned not to place undue reliance on any forward-looking statements in this document, as they reflect Universal Display Corporation’s current views with respect to future events and are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated. These risks and uncertainties are discussed in greater detail in Universal Display Corporation’s periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission, including, in particular, the section entitled “Risk Factors” in Universal Display Corporation’s Annual Report on Form 10-K for the year ended December 31, 2021. Universal Display Corporation disclaims any obligation to update any forward-looking statement contained in this document.

 

Follow Universal Display Corporation

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(OLED-C)

Contacts

Universal Display Contact:
Darice Liu

investor@oled.com
media@oled.com
+1 609-964-5123

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Business

PGIM Closed-End Funds declare distributions for June, July and August 2022

NEWARK, N.J. — (BUSINESS WIRE) — PGIM High Yield Bond Fund, Inc. (NYSE: ISD), PGIM Global High Yield Fund, Inc. (NYSE: GHY) and PGIM Short Duration High Yield Opportunities Fund (NYSE: SDHY) declared today monthly distributions for June, July and August 2022. The distribution amounts and schedule for each fund appears below:

Fund Name

Ticker

Distribution

Per Share

Change from Prior

Distribution

PGIM High Yield Bond Fund, Inc.

ISD

$0.105

–

PGIM Global High Yield Fund, Inc.

GHY

$0.105

–

PGIM Short Duration High Yield Opportunities Fund

SDHY

$0.108

–

Month

Ex-Date

Record Date

Payable Date

June

6/16/2022

6/17/2022

6/30/2022

July

7/14/2022

7/15/2022

7/29/2022

August

8/11/2022

8/12/2022

8/31/2022

 

The distribution amounts are forward-looking and may include net investment income, currency gains, capital gains and a return of capital, but such a determination cannot be made at this time. This press release is not for tax reporting purposes but is being provided to announce the amount of each Fund’s distributions that have been declared by the applicable Board of Directors.

 

In early 2023, after definitive information is available, each Fund will send shareholders a Form 1099-DIV, if applicable, specifying how the distributions paid by each Fund during the prior calendar year should be characterized for purposes of reporting the distributions on a shareholder’s tax return (e.g., ordinary income, long-term capital gain, or return of capital). If applicable, and when available, a current estimate of the distribution’s composition can be found in the Section 19 notice section of the website. Please consult your tax advisor for further information.

 

ABOUT PGIM INVESTMENTS

PGIM Investments, LLC and its affiliates offer more than 100 funds globally across a broad spectrum of asset classes and investment styles. All products draw on PGIM’s globally diversified investment platform that encompasses the expertise of managers across fixed income, equities, alternatives and real estate.

 

ABOUT PGIM

PGIM, the global asset management business of Prudential Financial, Inc. (NYSE: PRU), ranks among the top 10 largest asset managers in the world1 with approximately $1.4 trillion in assets under management as of March 31, 2022. With offices in 17 countries, PGIM’s businesses offer a range of investment solutions for retail and institutional investors around the world across a broad range of asset classes, including public fixed income, private fixed income, fundamental equity, quantitative equity, real estate and alternatives. For more information about PGIM, visit pgim.com.

 

Prudential Financial, Inc. (PFI) of the United States is not affiliated in any manner with Prudential plc, incorporated in the United Kingdom, or with Prudential Assurance Company, a subsidiary of M&G plc, incorporated in the United Kingdom. For more information please visit news.prudential.com.

 

1

Prudential Financial, Inc. (PFI) is the 10th-largest investment manager (out of 477) in terms of global AUM based on the Pensions & Investments Top Money Managers list published on May 31, 2021. This ranking represents assets managed by Prudential Financial as of Dec. 31, 2020.

 

Data and commentary provided in this press release are for informational purposes only. PGIM Investments LLC, the Investment Manager of the Fund, and its affiliates do not engage in selling shares of the Fund.

 

Each Fund is a diversified, closed-end management investment company managed by PGIM Investments LLC and subadvised by PGIM Fixed Income, a business unit of PGIM, Inc., and an affiliate of the investment manager.

 

These Funds invest in high yield (“junk”) bonds, which are subject to greater credit and market risks, including greater risk of default; derivative securities, which may carry market, credit, and liquidity risks; foreign securities, which are subject to currency fluctuation and political uncertainty; and emerging markets securities, which are subject to greater volatility and price declines. Fixed income investments are subject to interest rate risk, where their value will decline as interest rates rise. There are fees and expenses involved with investing in these Funds. Diversification does not assure a profit or protect against a loss in declining markets. There is no guarantee that dividends or distributions will be paid.

 

An investment in a closed-end fund’s common stock may be speculative in that it involves a high degree of risk, should not constitute a complete investment program, and may result in loss of principal. Each closed-end fund will have its own unique investment strategy, risks, charges and expenses that need to be considered before investing.

 

This material is being provided for informational or educational purposes only and does not take into account the investment objectives or financial situation of any client or prospective clients. The information is not intended as investment advice and is not a recommendation. Clients seeking information regarding their particular investment needs should contact a financial professional. Please consult with a qualified investment professional if you wish to obtain investment advice.

 

PGIM Fixed Income is a unit of PGIM, Inc., which is a registered investment advisor and Prudential Financial company. © 2022 Prudential Financial, Inc. and its related entities. PGIM and the PGIM logo are service marks of Prudential Financial, Inc. and its related entities, registered in many jurisdictions worldwide.

 

Investment products are not insured by the FDIC or any federal government agency, may lose value, and are not a deposit of or guaranteed by any bank or any bank affiliate.

 

1060189-00001-00 Expiration: 5/31/2023

Contacts

MEDIA CONTACT:
Kylie Scott

+1 973 902 2503

kylie.scott@pgim.com

CONNECT WITH US:
Visit pgim.com
Join the conversation on Twitter @PGIM

Categories
Business Lifestyle Technology

Infinitely expand your home automation system with Ezlo’s new smart home bundle.

Ezlo Innovation’s latest release pairs a powerful edge computing hub and video doorbell with lightning-fast video replay. The bundle provides the perfect foundation for a powerful, secure, and easily scalable smart home system.

 

BLOOMFIELD, N.J. — (BUSINESS WIRE) — Ezlo Innovation, a leading IoT platform developer, today launched a new smart home bundle, designed to connect with anything to create an entire, whole home automation solution. The bundle features a new doorbell with InstaVue technology and an edge computing controller, called Ezlo Plus, which is able to control the latest Z-Wave, Zigbee, and RF devices along with thousands of Wi-Fi products to enable an infinitely scalable and cost effective smart home.

The video doorbell camera, VistaCam 1203 featuring InstaVue™ technology, offers one of the fastest video replays on the market; under one second on a local connection and under two seconds on a remote connection. Ezlo Plus, the new computing hub, processes data at “the edge” — that is at the end point device, locally as opposed to the Cloud — resulting in both enhanced device response time and improved data security. The Ezlo plus also offers cloud processing for remote access.

 

“Critically important when it comes to the performance of any smart home device – especially a doorbell camera, is latency,” says Mark Samuel, CEO Ezlo Innovation. “By bringing two technologies together — InstaVue™ technology and edge computing — we’ve developed a camera that presents replay in less than one second which is faster than any other doorbell camera on the market. And, with the Plus hub’s ability to seamlessly integrate any device regardless of manufacturer or protocol, a bundle that will serve as the foundation for an entire smart home configuration.”

 

What does this mean to the end user? Now they can view video of events as they take place at the entryway of their home…and not seconds later. “And with nearly 50 million package thefts last year,” says Samuel, “those seconds can be the difference between knowing that a delivered package is safe and watching someone’s back as they run off with it.”

 

About Ezlo Innovation

Ezlo Innovation is a leading IoT platform developer, powering the digital journey across a range of markets; security solutions dealers, property management companies, builders, utilities, B2C retail and more.

 

Our open architecture automation solution, with guaranteed out-of-the-box integration, is the only platform that runs both in the Cloud and at the Edge, with the capability to automate, integrate, and visualize — in customizable dashboard form — any device, service, app, or IoT.

 

We are the only B2B company that can deliver a cloud-to-ground, white-label IoT solution to brands that want to offer their customers a connected technology service, delivering best-in-class solutions to both the residential and enterprise user in 60 countries worldwide. The company employs nearly 200 and is headquartered in Bloomfield, New Jersey, with offices in Ukraine, Romania, and Colombia. Learn more at www.ezlo.com.

Contacts

Media

Anne Marie Murray

Senior Director of Product Marketing

+1.973.809.5232

Anne.marie@ezlo.com

Categories
Business Healthcare Local News Science

U.S. Food and Drug Administration approves two Opdivo® (nivolumab)-based regimens as first-line treatments for unresectable advanced or metastatic esophageal squamous cell carcinoma

Opdivo in combination with chemotherapy and Opdivo plus Yervoy® (ipilimumab) approved based on a Phase 3 trial showing improved overall survival versus chemotherapy alone1,2

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers1

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #CheckMate—Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved both Opdivo® (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo® plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of PD-L1 status. The approvals are based on the Phase 3 CheckMate -648 trial, which evaluated Opdivo in combination with chemotherapy (n=321) and Opdivo plus Yervoy (n=325) each compared to chemotherapy alone (n=324), and was the largest Phase 3 trial of an immunotherapy in first-line ESCC.1

In the trial, Opdivo in combination with chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, both in all randomized patients, a secondary endpoint, which was hierarchically tested (Hazard Ratio [HR] 0.74, 95% Confidence Interval [CI]: 0.61 to 0.90, P=0.0021) and in patients whose tumors express PD-L1 (≥1%), a primary endpoint (HR 0.54, 95% CI: 0.41 to 0.71, P<0.0001).1,2 In all randomized patients the median OS (mOS) was 13.2 months (95% CI: 11.1 to 15.7) with Opdivo in combination with chemotherapy versus 10.7 months (95% CI: 9.4 to 11.9) with chemotherapy alone.1 In patients whose tumors express PD-L1 (≥1%) the mOS was 15.4 months (95% CI: 11.9 to 19.5) for Opdivo in combination with chemotherapy versus 9.1 months (95% CI: 7.7 to 10) with chemotherapy alone.1 The median progression-free survival (PFS) in all randomized patients, which was a hierarchically tested secondary endpoint, was 5.8 months (95% CI: 5.6 to 7.0) for Opdivo in combination with chemotherapy and 5.6 months (95% CI: 4.3 to 5.9) for chemotherapy alone (HR= 0.81; 95% CI: 0.67 to 0.99, P=not significant). Per pre-specified analysis, PFS did not meet statistical significance.1 The median PFS in patients whose tumors express PD-L1 (≥1%), which was a co-primary endpoint, was 6.9 months (95% CI: 5.7 to 8.3) for Opdivo in combination with chemotherapy and 4.4 months (95% CI: 2.9 to 5.8) for chemotherapy alone (HR 0.65; 95% CI: 0.49 to 0.86, P=0.0023).1

 

Opdivo plus Yervoy also improved OS compared to chemotherapy in all-randomized patients, a secondary endpoint, which was hierarchically tested (HR 0.78, 95% CI: 0.65 to 0.95, P=0.0110) and patients whose tumors express PD-L1 (≥1%), a primary endpoint (HR 0.64, 95% CI: 0.49 to 0.84, P=0.0010).1,2 The mOS was 12.8 months (95% CI: 11.3 to 15.5) with Opdivo plus Yervoy versus 10.7 months (95% CI: 9.4 to 11.9) with chemotherapy alone in all randomized patients and 13.7 months (95% CI: 11.2 to 17.0) with Opdivo plus Yervoy versus 9.1 months (95% CI: 7.7 to 10) with chemotherapy alone in patients whose tumors express PD-L1 (≥1%).1 The median PFS in patients whose tumors express PD-L1 (≥1%), which was a co-primary endpoint, was 4.0 months (95% CI: 2.4 to 4.9) for Opdivo plus Yervoy and 4.4 months (95% CI: 2.9 to 5.8) for chemotherapy alone (HR 1.02; 95% CI: 0.78 to 1.34, P=not significant). Per pre-specified analysis, PFS did not meet statistical significance.1,2 Median PFS in the PD-L1 (≥1%) population was not statistically significant and therefore it was not hierarchically tested in the all comers population.

 

Opdivo alone and Opdivo plus Yervoy are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1 Please see the Important Safety Information section below.

 

“Today brings welcome news for many advanced or metastatic esophageal squamous cell carcinoma patients and oncologists,” said Jaffer A. Ajani, M.D., CheckMate -648 co-first author and lead U.S. investigator, and professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “Unresectable advanced or metastatic esophageal squamous cell carcinoma is a challenging disease, and there’s a need for additional treatment options that may extend survival in the first-line setting.3,4 In the CheckMate -648 trial, two nivolumab-based combinations showed a survival benefit compared to chemotherapy alone, offering new treatment options regardless of PD-L1 status.”1

 

This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.5

 

“At Bristol Myers Squibb, we recognize the need that exists for many patients facing upper gastroesophageal cancers, including advanced or metastatic esophageal squamous cell carcinoma, and we are focused on our goal to bring forward new treatment options with proven survival benefits regardless of PD-L1 status and histology,” said Adam Lenkowsky, senior vice president and general manager, U.S., Cardiovascular, Immunology, Oncology, Bristol Myers Squibb.6 “Today’s approvals bring two first-line immunotherapy-based treatment options at once, Opdivo in combination with chemotherapy and Opdivo plus Yervoy as the first dual immunotherapy option, to newly diagnosed patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, further building on the role of Opdivo-based regimens in upper gastroesophageal cancers.”1

 

About CheckMate -648

CheckMate -648 is a randomized Phase 3 study evaluating Opdivo plus Yervoy or Opdivo in combination with chemotherapy (fluorouracil and cisplatin) against chemotherapy (fluorouracil plus cisplatin) alone in adult patients with previously untreated unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.1,2 The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) determined by blinded independent central review (BICR) in patients whose tumors express PD-L1 (≥1%) for both Opdivo-based combinations versus chemotherapy.2 Secondary endpoints of the trial, including OS and PFS as determined by BICR in the all randomized population, were tested hierarchically only if corresponding primary endpoints were significant.1,2

 

In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 2 years or until disease progression or unacceptable toxicity.1,2 In the Opdivo in combination with chemotherapy arm, patients received treatment with Opdivo 240 mg on Day 1 and Day 15, fluorouracil 800 mg/m²/day on Day 1 through Day 5 for five days, and cisplatin 80 mg/m² on Day 1 of a four-week cycle.1,2 Patients were treated with Opdivo until disease progression, unacceptable toxicity, or up to 2 years.1,2 In patients who received Opdivo in combination with chemotherapy and in whom either fluorouracil and/or cisplatin were discontinued, other components of the treatment regimen were allowed to be continued. 2 Patients who discontinued combination therapy because of an adverse reaction attributed to ipilimumab were permitted to continue Opdivo as a single agent.2

 

Select Safety Profile from CheckMate -648 Study

Opdivo and/or chemotherapy were discontinued in 39% of patients and were delayed in 71% of patients for an adverse reaction.1 Serious adverse reactions occurred in 62% of patients receiving Opdivo in combination with chemotherapy.1 The most frequent (≥2%) serious adverse reactions in patients receiving Opdivo in combination with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%).1 Fatal adverse reactions occurred in 5 (1.6%) patients treated with Opdivo in combination with chemotherapy; these included pneumonitis, pneumatosis intestinalis, pneumonia, and acute kidney injury.1 The most common (≥20%) adverse reactions in patients treated with Opdivo in combination with chemotherapy were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%).1

 

Opdivo and/or Yervoy were discontinued in 23% of patients and were delayed in 46% of patients for an adverse reaction.1 Serious adverse reactions occurred in 69% of patients receiving Opdivo plus Yervoy.1 The most frequent (≥2%) serious adverse reactions in patients receiving Opdivo plus Yervoy were pneumonia (10%), pyrexia (4.3%), pneumonitis (4%), aspiration pneumonia (3.7%), dysphagia (3.7%), hepatic function abnormal (2.8%), decreased appetite (2.8%), adrenal insufficiency (2.5%), and dehydration (2.5%).1 Fatal adverse reactions occurred in 5 (1.6%) patients treated with Opdivo plus Yervoy; these included pneumonitis, interstitial lung disease, pulmonary embolism, and acute respiratory distress syndrome.1 The most common (≥20%) adverse reactions in patients treated with Opdivo plus Yervoy were rash (31%), fatigue (28%), pyrexia (23%), nausea (22%), diarrhea (22%), and constipation (20%).1

 

About Esophageal Cancer

In the United States, it is estimated that approximately 20,640 new cases of esophageal cancer will be diagnosed and approximately 16,410 deaths will result from the disease in 2022 alone.7 Esophageal cancer, which can impact the patient’s ability to swallow and eat, is a type of gastroesophageal cancer that starts in the inner layer of the esophagus (the mucosa) and grows.8,9 The mucosa is normally lined with squamous cells.9 Cancer starting in these cells is called squamous cell carcinoma, which is most often found in the upper and middle part of the esophagus, and accounts for less than 30% of esophageal cancers in the United States.9 For about 39% of patients, esophageal cancer is diagnosed in the advanced stage, which is typically harder to treat.10

 

INDICATIONS

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

 

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

 

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

 

OPDIVO® (nivolumab), in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

 

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

 

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

 

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%).

 

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

 

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

 

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

 

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis.

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

 

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

 

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

 

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO.

 

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.

 

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

 

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.

 

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

 

Lactation

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production.

Contacts

Bristol Myers Squibb
Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

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Business Culture

Best’s Special Report: First-quarter 2022 results show 5% increase in U.S. property/casualty industry’s underwriting income

OLDWICK, N.J. — (BUSINESS WIRE) — The U.S. property/casualty (P/C) industry saw a 4.6% increase to $3.3 billion in net underwriting income in the first three months of 2022 over the same prior-year period, according to preliminary financial results. This financial review is detailed in a new Best’s Special Report, “First Look: Three-Month 2022 U.S. Property/Casualty Financial Results,” and the data is derived from companies’ three-month 2022 interim statutory statements that were received as of May 20, 2022, representing an estimated 95% of the total P/C industry’s net premiums written.

According to the report, the combined ratio for the P/C industry improved marginally to 96.3 in the first quarter of 2022 from 96.6 in the first quarter of 2021. Catastrophe losses accounted for an estimated 3.3 points on the three-month 2022 combined ratio, down from an estimated 8.7 points in the prior-year period. A 39.7% decline in policyholder dividends and 10.5% growth in net earned premiums was offset by increases in incurred losses, loss adjustment expenses and underwriting expenses, leading to the modest underwriting income increase. Overall P/C industry net income rose $29.0 billion for the three-month period.

 

Industry surplus increased slightly by 0.5% from the end of 2021 to $1.0 trillion, as the net income plus other surplus gains of $8.4 billion were reduced by $32.1 billion of unrealized losses and stockholder dividends.

 

To access the full copy of this special report, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=320298.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Matthew Coppola
Director, Data Management
+1 908 439 2200, ext. 5627
matthew.coppola@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Jeff Mango
Managing Director,
Strategy & Communications
+1 908 439 2200, ext. 5204
jeffrey.mango@ambest.com

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Business Culture Lifestyle

Zoetis to participate in the Stifel 2022 Jaws and Paws Conference

PARSIPPANY, N.J. — (BUSINESS WIRE) — $ZTS #animalhealth—Zoetis Inc. (NYSE:ZTS) will participate in the Stifel 2022 Jaws and Paws Conference on Wednesday, June 1, 2022. Glenn David, Executive Vice President and Group President, International Operations, Aquaculture, BioDevices and Pet Insurance, will represent the company and respond to questions from analysts. He is scheduled to present at 4:10 p.m. ET.

Investors and other interested parties will be able to access a live audio webcast of the presentation by visiting http://investor.zoetis.com/events-presentations. A replay of the presentation will also be available on the Zoetis website after the event.

 

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide — from livestock farmers to veterinarians and pet owners. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $7.8 billion in 2021 with approximately 12,100 employees. For more information, visit www.zoetis.com.

 

ZTS-COR

ZTS-IR

ZTS-FIN

Contacts

Media:

Bill Price

1-973-443-2742 (o)

william.price@zoetis.com

Kristen Seely

1-973-443-2777 (o)

kristen.seely@zoetis.com

Investor:

Steve Frank

1-973-822-7141 (o)

steve.frank@zoetis.com